Chronic Graft-Versus-Host-Disease Clinical Trial
Official title:
Development and Validation of a Symptom Scale for Children With Chronic Graft-Versus-Host Disease
Verified date | February 6, 2018 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Chronic graft-vs-host disease (GVHD) is an important cause of morbidity and mortality in
patients undergoing allogeneic bone marrow transplantation. The symptoms of chronic GVHD
are similar to those of other autoimmune diseases, and treatment for the pain often
involves steroid use that can cause severe side effects over the long term.
- At present, there is no research instrument that measures symptoms in children with
chronic GVHD. Treatment practitioners may use one of several pediatric quality of life
questionnaires, but because none of these is specific for chronic GVHD each instrument
has potential gaps in its ability to assess the full spectrum of problems experienced by
children with chronic GVHD. Researchers are interested in developing a better
understanding of the disease burden experienced by children and adolescents with chronic
GVHD.
Objectives:
- To develop a Pediatric Chronic GVHD Symptom Scale (PCSS) that reliably measures the
disease-specific burden of chronic GVHD in children.
Eligibility:
- Children and adolescents 5 to 18 years of age who have undergone prior allogeneic stem cell
transplant and have been diagnosed with chronic GVHD that requires treatment.
Design:
- There are two phases to the study; participants will enroll in phase I (question
generation) at this time.
- Researchers will interview participants and ask open-ended questions (requiring more
than a one- or two-word response) about symptoms that adults with chronic GVHD have
found problematic.
- Both parents and children will participate in the interviews, which will be
audio-recorded. Depending on the child or adolescent s age, the interviews may be
conducted together with the parents or separately.
- No treatment will be given as part of this study.
Status | Completed |
Enrollment | 3 |
Est. completion date | February 6, 2018 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
- INCLUSION CRITERIA: - Children of 5 to 18 years of age, who have undergone prior allogeneic stem cell transplant. - Clinical diagnosis of chronic GVHD with need for systemic treatment. - No evidence of primary disease relapse. - Must be willing to sign informed consent, or if applicable, child assent. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Champlin RE, Gale RP. The early complications of bone marrow transplantation. Semin Hematol. 1984 Apr;21(2):101-8. Review. — View Citation
Sullivan KM, Parkman R. The pathophysiology and treatment of graft-versus-host disease. Clin Haematol. 1983 Oct;12(3):775-89. Review. — View Citation
Thomas E, Storb R, Clift RA, Fefer A, Johnson FL, Neiman PE, Lerner KG, Glucksberg H, Buckner CD. Bone-marrow transplantation (first of two parts). N Engl J Med. 1975 Apr 17;292(16):832-43. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Develop pediatric cGVHD symptom scale | 24 months | ||
Secondary | Rasch measurement model, determine sensitivity to use in clinicalintervention trials | 24 months | ||
Secondary | Correlate scores with QOL measures | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04189432 -
Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
|
Phase 2 | |
Terminated |
NCT03557749 -
Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
|
||
Completed |
NCT05121142 -
Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease
|
Phase 1 | |
Recruiting |
NCT04202835 -
ATG Plus PTCy vs ATG for CGVHD Prophylaxis
|
Phase 2 | |
Terminated |
NCT03640481 -
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
|
Phase 2 | |
Recruiting |
NCT04372524 -
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
|
||
Active, not recruiting |
NCT03604692 -
A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD
|
Phase 1/Phase 2 | |
Recruiting |
NCT05355675 -
The Association of Microbiota Composition With cGVHD After Allo-HSCT
|
||
Active, not recruiting |
NCT04710576 -
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
|
Phase 2 | |
Terminated |
NCT04200365 -
A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)
|
Phase 2 | |
Not yet recruiting |
NCT06263478 -
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease
|
Phase 3 | |
Not yet recruiting |
NCT06388564 -
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
|
Phase 2 | |
Terminated |
NCT02123966 -
An Open Label Phase II Trial of Topical Sirolimus for the Treatment of Refractory Oral Chronic Graft-versus-Host-Disease
|
Phase 2 | |
Recruiting |
NCT05692713 -
Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease (ABLE3.0/CTTC2201)
|
||
Terminated |
NCT04446182 -
Itacitinib (INCB039110) and Extracorporeal Photopheresis (ECP) for First-Line Treatment in Chronic GVHD
|
Phase 2 | |
Active, not recruiting |
NCT05305989 -
Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213
|
Phase 2 | |
Active, not recruiting |
NCT02340676 -
A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD
|
Phase 2 | |
Completed |
NCT04540133 -
Dexamethasone Solution and Dexamethasone in Mucolox™
|
Phase 2 | |
Not yet recruiting |
NCT03190733 -
A Optimal Anti-Thymoglobuline (ATG) Dose Decrease cGVHD But Not Increase Leukemia Relapse for Haplo-HSCT
|
Phase 4 | |
Active, not recruiting |
NCT04716075 -
Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT)
|
Phase 2 |